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Original New Drug Approvals (NDAs and BLAs) by MonthAll applications approved for the first time during the selected month. Includes New Molecular Entities (NMEs) and new biologics. Not all biologics are in Drugs@FDA.
Does not include tentative approvals.

Original Abbreviated New Drug Approvals (ANDAs) by MonthGeneric Drug Approvals. Does not include tentative approvals.

Supplements to New Drug Applications (NDAs and BLAs) by Month Supplemental approvals to NDAs and BLAs